Application 214567

Type: ANDA
Sponsor: APOTEX

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LACOSAMIDE	LACOSAMIDE	TABLET;ORAL	50MG	No	No
002	LACOSAMIDE	LACOSAMIDE	TABLET;ORAL	100MG	No	No
003	LACOSAMIDE	LACOSAMIDE	TABLET;ORAL	150MG	No	No
004	LACOSAMIDE	LACOSAMIDE	TABLET;ORAL	200MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A214567-001	LACOSAMIDE	LACOSAMIDE	50MG	TABLET / ORAL	2022-09-23
A214567-002	LACOSAMIDE	LACOSAMIDE	100MG	TABLET / ORAL	2022-09-23
A214567-003	LACOSAMIDE	LACOSAMIDE	150MG	TABLET / ORAL	2022-09-23
A214567-004	LACOSAMIDE	LACOSAMIDE	200MG	TABLET / ORAL	2022-09-23

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 112 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A214567-001	LACOSAMIDE	50MG	TABLET / ORAL	2022-09-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214567-002	LACOSAMIDE	100MG	TABLET / ORAL	2022-09-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214567-003	LACOSAMIDE	150MG	TABLET / ORAL	2022-09-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214567-004	LACOSAMIDE	200MG	TABLET / ORAL	2022-09-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A214567-001	LACOSAMIDE	50MG	TABLET / ORAL	2022-09-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214567-002	LACOSAMIDE	100MG	TABLET / ORAL	2022-09-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214567-003	LACOSAMIDE	150MG	TABLET / ORAL	2022-09-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214567-004	LACOSAMIDE	200MG	TABLET / ORAL	2022-09-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214567-001	LACOSAMIDE	50MG	TABLET / ORAL	2022-09-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214567-002	LACOSAMIDE	100MG	TABLET / ORAL	2022-09-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214567-003	LACOSAMIDE	150MG	TABLET / ORAL	2022-09-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214567-004	LACOSAMIDE	200MG	TABLET / ORAL	2022-09-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214567-001	LACOSAMIDE	50MG	TABLET / ORAL	2022-09-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214567-002	LACOSAMIDE	100MG	TABLET / ORAL	2022-09-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214567-003	LACOSAMIDE	150MG	TABLET / ORAL	2022-09-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214567-004	LACOSAMIDE	200MG	TABLET / ORAL	2022-09-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214567-001	LACOSAMIDE	50MG	TABLET / ORAL	2022-09-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214567-002	LACOSAMIDE	100MG	TABLET / ORAL	2022-09-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214567-003	LACOSAMIDE	150MG	TABLET / ORAL	2022-09-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214567-004	LACOSAMIDE	200MG	TABLET / ORAL	2022-09-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214567-001	LACOSAMIDE	50MG	TABLET / ORAL	2022-09-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214567-002	LACOSAMIDE	100MG	TABLET / ORAL	2022-09-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214567-003	LACOSAMIDE	150MG	TABLET / ORAL	2022-09-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214567-004	LACOSAMIDE	200MG	TABLET / ORAL	2022-09-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214567-001	LACOSAMIDE	50MG	TABLET / ORAL	2022-09-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214567-002	LACOSAMIDE	100MG	TABLET / ORAL	2022-09-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214567-003	LACOSAMIDE	150MG	TABLET / ORAL	2022-09-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214567-004	LACOSAMIDE	200MG	TABLET / ORAL	2022-09-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214567-001	LACOSAMIDE	50MG	TABLET / ORAL	2022-09-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214567-002	LACOSAMIDE	100MG	TABLET / ORAL	2022-09-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214567-003	LACOSAMIDE	150MG	TABLET / ORAL	2022-09-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214567-004	LACOSAMIDE	200MG	TABLET / ORAL	2022-09-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214567-001	LACOSAMIDE	50MG	TABLET / ORAL	2022-09-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214567-002	LACOSAMIDE	100MG	TABLET / ORAL	2022-09-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214567-003	LACOSAMIDE	150MG	TABLET / ORAL	2022-09-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214567-004	LACOSAMIDE	200MG	TABLET / ORAL	2022-09-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214567-001	LACOSAMIDE	50MG	TABLET / ORAL	2022-09-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214567-002	LACOSAMIDE	100MG	TABLET / ORAL	2022-09-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214567-003	LACOSAMIDE	150MG	TABLET / ORAL	2022-09-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214567-004	LACOSAMIDE	200MG	TABLET / ORAL	2022-09-23	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2023-01-26 05:58 UTC	2023-01	A214567-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A214567-002	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A214567-003	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A214567-004	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A214567-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A214567-002	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A214567-003	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A214567-004	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A214567-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A214567-002	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A214567-003	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A214567-004	AB	1	`f41ea6bd6efb…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 2 of 4 · 68 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lacosamide Oral Solution	LACOSAMIDE	Chartwell Governmental & Specialty RX, LLC.	e265fd09-8149-4423-a317-5760d34b8e9b	2026-02-25	Warnings, Adverse reactions	Name fallback generic name: LACOSAMIDE
Lacosamide	LACOSAMIDE	Kanchan Healthcare Inc	41f02424-231d-4039-a122-df4b49dc9998	2026-01-29	Warnings, Adverse reactions	Name fallback brand name: Lacosamide generic name: LACOSAMIDE
LACOSAMIDE	LACOSAMIDE	Anthea Pharma Private Limited	b4f2620a-2047-4b33-bb75-18702f6c55e6	2026-01-24	Warnings, Adverse reactions	Name fallback brand name: LACOSAMIDE generic name: LACOSAMIDE
LACOSAMIDE	LACOSAMIDE	GLENMARK PHARMACEUTICALS INC., USA	bc7ed8a6-acce-48f2-9ef1-4e366c71dbbc	2026-01-24	Warnings, Adverse reactions	Name fallback brand name: LACOSAMIDE generic name: LACOSAMIDE
LACOSAMIDE	LACOSAMIDE	Virtus Pharmaceuticals, LLC	01162e2f-967b-4596-8188-c0d9889c3814	2026-01-23	Warnings, Adverse reactions	Name fallback brand name: LACOSAMIDE generic name: LACOSAMIDE
Lacosamide	LACOSAMIDE	Sintetica US LLC	08ac486a-4f61-4e9e-9683-d1a66a6c2a4d	2026-01-04	Warnings, Adverse reactions	Name fallback brand name: Lacosamide generic name: LACOSAMIDE
Lacosamide Oral Solution	LACOSAMIDE	Ajenat Pharmaceuticals LLC	cb29da34-89aa-405a-8fbc-2308bda37187	2025-12-29	Warnings, Adverse reactions	Name fallback generic name: LACOSAMIDE
lacosamide	LACOSAMIDE	Glenmark Pharmaceuticals Inc. USA	df1d2e6a-6129-49c9-b2c1-0fdf73f38b9c	2025-12-17	Warnings, Adverse reactions	Name fallback brand name: lacosamide generic name: LACOSAMIDE
Lacosamide Oral Solution	LACOSAMIDE	Kesin Pharma Corporation	446f14be-5d79-26b9-e063-6294a90ae0b5	2025-11-25	Warnings, Adverse reactions	Name fallback generic name: LACOSAMIDE
LACOSAMIDE	LACOSAMIDE	ScieGen Pharmaceuticals Inc	f4ffa3ad-1278-4772-9ef8-ed6fdaa47605	2025-10-31	Warnings, Adverse reactions	Name fallback brand name: LACOSAMIDE generic name: LACOSAMIDE
Lacosamide	LACOSAMIDE	Kanchan Healthcare Inc	5c03b90e-6985-4005-b6c5-44626d0600d7	2025-10-19	Warnings, Adverse reactions	Name fallback brand name: Lacosamide generic name: LACOSAMIDE
Lacosamide	LACOSAMIDE	NorthStar RxLLC	9dffda6c-9e44-478f-9e02-9da3ab4c50e1	2025-10-05	Warnings, Adverse reactions	Name fallback brand name: Lacosamide generic name: LACOSAMIDE
Lacosamide	LACOSAMIDE	Camber Pharmaceuticals, Inc.	bbd80370-3d23-41f8-8914-c6ea897c0154	2025-09-29	Warnings, Adverse reactions	Name fallback brand name: Lacosamide generic name: LACOSAMIDE
Lacosamide	LACOSAMIDE	Ascend Laboratories, LLC	9d7fde23-dc3f-41e9-89cf-6a1a9eeaa7de	2025-08-11	Warnings, Adverse reactions	Name fallback brand name: Lacosamide generic name: LACOSAMIDE
Lacosamide Oral Solution	LACOSAMIDE	Kesin Pharmaceutical Corporation	3ba29442-4e8a-c2b2-e063-6294a90a1bbf	2025-08-05	Warnings, Adverse reactions	Name fallback generic name: LACOSAMIDE
Lacosamide	LACOSAMIDE	Westminster Pharmaceuticals, LLC	61e3747a-3957-4840-81f0-313aefbd5d2b	2025-07-29	Warnings, Adverse reactions	Name fallback brand name: Lacosamide generic name: LACOSAMIDE
MOTPOLY XR	LACOSAMIDE	Aucta Pharmaceuticals, Inc.	fb8235b4-4cd3-6f22-e053-6294a90a545c	2025-07-16	Warnings, Adverse reactions	Name fallback generic name: LACOSAMIDE
Lacosamide	LACOSAMIDE	ANI Pharmaceuticals, Inc.	68033c90-d9cc-4d5f-896c-9a61a0c3b529	2025-06-25	Warnings, Adverse reactions	Name fallback brand name: Lacosamide generic name: LACOSAMIDE
Lacosamide	LACOSAMIDE	Advanced Rx of Tennessee, LLC	325df1b7-4908-0c03-e063-6294a90ad844	2025-04-09	Warnings, Adverse reactions	Name fallback brand name: Lacosamide generic name: LACOSAMIDE
LACOSAMIDE	LACOSAMIDE	Precision Dose, Inc.	fe24b28b-ca15-4dfd-a198-53cdc2c8cb99	2025-03-31	Warnings, Adverse reactions	Name fallback brand name: LACOSAMIDE generic name: LACOSAMIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.